Since 1991, many clinical studies have been conducted for gene therapies for cancer. These studies have succeeded in confirming its safety, however complete cure has not achieved yet and not all of cancer cells in patients' body could be killed. In the first half of 1990s, ex vivo gene therapies with retroviruses were carried out as gene therapy clinical studies for cancers, in that therapies cytokine genes or the like of inducing immunity were transfected into cancer cells in vitro and the cancer cells were inactivated their growth ability by radioactivity and then the cancer cells were returned into the patient's body. These ex vivo therapies were not achieved to give pharmaceutical products, because of many problems such as clinical maneuvers required and insufficient effects. In the 1990s, the in vivo gene therapy clinical studies were performed by direct administration of non-replicating vectors such as an adenovirus into tumor cells in vivo, and that proceed clinical development of the drugs for that therapies. In the 2000s, gene therapies using a cancer specific replicating virus has been studied and developed and the clinical studies have been carried out.
Recently, the inventor originally developed a technique that effectively produce cancer specific adenovirus vectors controlled by multiple factors as a next generation cancer specific replicating virus (Patent Document 1), and have preceded the development of the cancer gene therapy technique using the adenovirus vector (Patent Document 2).
The Aurora kinase was known as a kinase to control various events in cell division stages. Aurora-A, B, and C were identified presently. It has been reported that these kinases are expressed at higher levels in many human cancer cells than in normal cells (Non-patent Documents 1 to 4). However, those were only analytical reports for molecular functions, and there was no report for the Aurora kinase promoters investigated from a view of gene therapies. The gene therapy technique using a vector containing the Aurora kinase promoter has not been disclosed in the past, and there is no precedent case in which the promoter was used for other treatment use.